NCT00123487 · BASELINE

Baseline characteristics

Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML · Source last updated 2014-11-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
306
group Id
BG001
value
305
group Id
BG002
value
611
units
Participants

groups

description
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
id
BG000
title
Dasatinib 140 mg QD
description
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
id
BG001
title
Dasatinib 70 mg BID
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Less than (<) 21 years
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
83
group Id
BG002
value
184
title
21 - 45 years
categories
measurements
group Id
BG000
value
143
group Id
BG001
value
143
group Id
BG002
value
286
title
46 - 65 years
categories
measurements
group Id
BG000
value
49
group Id
BG001
value
65
group Id
BG002
value
114
title
66 - 75 years
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
17
title
Greater than (>) 75 years
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Not Reported
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
133
group Id
BG001
value
134
group Id
BG002
value
267
title
Female
measurements
group Id
BG000
value
173
group Id
BG001
value
171
group Id
BG002
value
344
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
38
group Id
BG002
value
76
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
35
title
Black or African American
categories
measurements
group Id
BG000
value
235
group Id
BG001
value
236
group Id
BG002
value
471
title
White
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
9
group Id
BG002
value
22
title
Other
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Unknown or Not reported
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
138
group Id
BG001
value
134
group Id
BG002
value
272
title
ECOG PS 0
categories
measurements
group Id
BG000
value
121
group Id
BG001
value
109
group Id
BG002
value
230
title
ECOG PS 1
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
58
group Id
BG002
value
98
title
ECOG PS 2
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
ECOG PS 3
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Not Reported
description
ECOG PS, a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale: 0-5, with 0= Fully active, able to carry on all pre-disease performance without restriction and 5=Death.
param Type
NUMBER
title
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
43
group Id
BG001
value
49
group Id
BG002
value
92
title
Primary Resistance
categories
measurements
group Id
BG000
value
192
group Id
BG001
value
190
group Id
BG002
value
382
title
Acquired Resistance
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
65
group Id
BG002
value
132
title
Intolerance
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Missing
description
Failure on prior treatment with imatinib due to either resistance to or intolerance of imatinib. Resistance: no hematologic response after a ≥ 4-week treatment or a ≥ 50% increase in blasts after a 2-week treatment (primary resistance); achieved a hematologic response, no longer met criteria consistently on all assessments over a consecutive 2-week period while receiving an imatinib (acquired resistance); progressed while on treatment. Intolerance: Grade ≥ 3 non-hematologic toxicity or a Grade 4 hematologic toxicity lasting for \> 2 weeks leading to discontinuation of therapy or dose decrease.
param Type
NUMBER
title
Imatinib Status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
158
group Id
BG001
value
159
group Id
BG002
value
317
title
Accelerated Phase CML
categories
measurements
group Id
BG000
value
75
group Id
BG001
value
74
group Id
BG002
value
149
title
Blast Phase CML - Myeloid
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
28
group Id
BG002
value
61
title
Blast Phase CML - Lymphoid
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
44
group Id
BG002
value
84
title
Ph+ ALL
description
Chronic Myelogenous Leukemia (CML) consists of a chronic phase lasting three to six years, followed by transformation to an accelerated phase (AP) and blast phases (myeloid and Lymphoid) of much shorter duration. The Philadelphia chromosome (Ph+) status was documented by cytogenetic analysis or by Fluorescent-In Situ Hybridization (FISH) for the presence of a protein kinase (BCR-ABL) on peripheral blood (PB) cells or bone marrow (BM) samples.
param Type
NUMBER
title
Participants by Disease Phase
unit Of Measure
participants

population Description

Randomized Population analyzed. Baseline data are based on what participants were randomized to receive and not what they actually received.

Complete source fields

denoms

counts
group Id
BG000
value
306
group Id
BG001
value
305
group Id
BG002
value
611
units
Participants

groups

description
Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
id
BG000
title
Dasatinib 140 mg QD
description
Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
id
BG001
title
Dasatinib 70 mg BID
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Less than (<) 21 years
categories
measurements
group Id
BG000
value
101
group Id
BG001
value
83
group Id
BG002
value
184
title
21 - 45 years
categories
measurements
group Id
BG000
value
143
group Id
BG001
value
143
group Id
BG002
value
286
title
46 - 65 years
categories
measurements
group Id
BG000
value
49
group Id
BG001
value
65
group Id
BG002
value
114
title
66 - 75 years
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
17
title
Greater than (>) 75 years
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Not Reported
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
133
group Id
BG001
value
134
group Id
BG002
value
267
title
Female
measurements
group Id
BG000
value
173
group Id
BG001
value
171
group Id
BG002
value
344
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
38
group Id
BG002
value
76
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
35
title
Black or African American
categories
measurements
group Id
BG000
value
235
group Id
BG001
value
236
group Id
BG002
value
471
title
White
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
9
group Id
BG002
value
22
title
Other
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Unknown or Not reported
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
138
group Id
BG001
value
134
group Id
BG002
value
272
title
ECOG PS 0
categories
measurements
group Id
BG000
value
121
group Id
BG001
value
109
group Id
BG002
value
230
title
ECOG PS 1
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
58
group Id
BG002
value
98
title
ECOG PS 2
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
ECOG PS 3
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Not Reported
description
ECOG PS, a 6-item scale to assess disease progression, daily functioning, and appropriate treatment and prognosis. Scale: 0-5, with 0= Fully active, able to carry on all pre-disease performance without restriction and 5=Death.
param Type
NUMBER
title
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
43
group Id
BG001
value
49
group Id
BG002
value
92
title
Primary Resistance
categories
measurements
group Id
BG000
value
192
group Id
BG001
value
190
group Id
BG002
value
382
title
Acquired Resistance
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
65
group Id
BG002
value
132
title
Intolerance
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Missing
description
Failure on prior treatment with imatinib due to either resistance to or intolerance of imatinib. Resistance: no hematologic response after a ≥ 4-week treatment or a ≥ 50% increase in blasts after a 2-week treatment (primary resistance); achieved a hematologic response, no longer met criteria consistently on all assessments over a consecutive 2-week period while receiving an imatinib (acquired resistance); progressed while on treatment. Intolerance: Grade ≥ 3 non-hematologic toxicity or a Grade 4 hematologic toxicity lasting for \> 2 weeks leading to discontinuation of therapy or dose decrease.
param Type
NUMBER
title
Imatinib Status
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
158
group Id
BG001
value
159
group Id
BG002
value
317
title
Accelerated Phase CML
categories
measurements
group Id
BG000
value
75
group Id
BG001
value
74
group Id
BG002
value
149
title
Blast Phase CML - Myeloid
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
28
group Id
BG002
value
61
title
Blast Phase CML - Lymphoid
categories
measurements
group Id
BG000
value
40
group Id
BG001
value
44
group Id
BG002
value
84
title
Ph+ ALL
description
Chronic Myelogenous Leukemia (CML) consists of a chronic phase lasting three to six years, followed by transformation to an accelerated phase (AP) and blast phases (myeloid and Lymphoid) of much shorter duration. The Philadelphia chromosome (Ph+) status was documented by cytogenetic analysis or by Fluorescent-In Situ Hybridization (FISH) for the presence of a protein kinase (BCR-ABL) on peripheral blood (PB) cells or bone marrow (BM) samples.
param Type
NUMBER
title
Participants by Disease Phase
unit Of Measure
participants

population Description

Randomized Population analyzed. Baseline data are based on what participants were randomized to receive and not what they actually received.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice